FDA 510(k)

潔淨潔淨 MAJESTY ES 流動

K 號：K191980 · 2019-11-18

決定日期2019-11-18

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

CLEARFIL MAJESTY ES Flow is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K191980. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CLEARFIL MAJESTY ES Flow?

CLEARFIL MAJESTY ES Flow is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K191980.

When did CLEARFIL MAJESTY ES Flow receive FDA 510(k) clearance?

CLEARFIL MAJESTY ES Flow received FDA 510(k) clearance on 2019-11-18, under 510(k) number K191980.

Who is the listed applicant for CLEARFIL MAJESTY ES Flow?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARFIL MAJESTY ES Flow?

The FDA product code for CLEARFIL MAJESTY ES Flow is EBF.

其他以 Kuraray Noritake Dental, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EBF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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